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PembrolizuMab beyond RECIST progression and oral metroNOmic cyclophosphamide in meTAstatic UROthelial cancer: a single-arm, monocentre, phase 2 trial: minotaURO study
EU CTIS ID: 2024-514979-17-04
What this study is testing
The primary endpoint is: non progressive rate at 6 months
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Age = 18 years; • Histological diagnosis of urothelial carcinoma, Advanced or metastatic disease; • PD-L1 expression: PD-L1 determined by immunohistochemistry (IHC; Dako 22C3 pharmDx assay; Agilent Technologies) at a local laboratory, with expressions scored using the combined positive score (CPS); • Eastern Cooperative Oncology Group performance status (ECOG PS) =2; • Adequate hematologic, renal, and hepatic function; RECIST 1.1 measurable disease; • Ongoing Pembrolizumab, as clinically indicated (progression after platinum-based chemotherapy); • Progression disease according to RECIST criteria; Criteria for receiving ICIs beyond RECIST v1.1 progression are: clinical benefit assessed by investigator, stable performance status, tolerance of treatment and no need to deliver immediate intervention to prevent serious complication of progression; iUPD(immune unconfirmed progressive disease according to iRECIST criteria); which require radiological confirmation; Oligometastatic disease: minimal metastatic state in which patients have a low burden of metastatic disease with only a small number of metastatic sites at initial presentation of their illness; Written informed consent
You likely can't join if
- • Condition requiring treatment with glucocorticoids (equivalent to >10 mg of prednisone daily); • Hyperprogression condiction definited as two-fold or greater increase in the tumor growth rate in terms of volume during immunotherapy or a time to treatment failure of less than 2 months or a greater than 50% increase in tumor burden in two diameters according to irRC compared with pre-immunotherapy imaging that was obtained within 2 months of the initiation of the immuno-oncology agent, or a greater than two fold increase in progression pace with one diameter or a two fold or greater increase in the tumor growth rate in one diameter on immunotherapy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.